(392 days)
This product is intended to be used in an MR environment for the Administration of Contrast and Flush for Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).
Not Found
The provided text is a 510(k) premarket notification approval letter for the "Smart Set" intravascular administration set. This document does not describe or contain information about acceptance criteria, a study that proves a device meets acceptance criteria, or any of the detailed study parameters requested (sample size, expert qualifications, ground truth, MRMC study, standalone performance, etc.).
The letter is a regulatory document confirming that the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies the device name, models, regulation number, regulatory class, and indications for use. It also outlines general compliance requirements.
Therefore, I cannot provide the requested information based on the given input text. The information needed to answer the prompt (acceptance criteria, study details, performance data) is not present in this regulatory approval letter.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.